minutes of 14th meeting of enlistment evaluation committee ... of 14th me… · nutraceuticals...

Minutes of 14th

Meeting of Enlistment Evaluation Committee (EEC)

held on 31st August, 2016

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No. F. 10-09/2016-DDC (Health & OTC)

Government of Pakistan

Ministry of National Health Services, Regulations & Coordination

DRUG REGULATORY AUTHORITY OF PAKISTAN

******

Islamabad, the 31st August, 2016

MINUTES OF THE 14TH

MEETING OF ENLISTMENT EVALUATION COMMITTEE FOR

ALTERNATIVE MEDICINES AND HEALTH PRODUCTS

14

th Meeting of the Enlistment Evaluation Committee (EEC), constituted under Rules 7 of the

Alternative Medicines and Health Products (Enlistment) Rules, 2014, was held in the office of the Chairman of

the Committee on 31st August, 2016. Meeting of Committee was attended by the following:-

S. #. Name & Designation Position in the Committee

1.

Abdul Samad Khan,

Director Health & OTC

Ex-Officio Chairman

2.

Abdul Sattar Sohrani,

Deputy Drug Controller Health & OTC

Ex-Officio Member / Secretary

3.

Homeopathic Dr. Muhammad Tariq Khan,

Assistant Professor,

Department College of Pharmacy,

Margalla Institute of Health Sciences, Rawalpindi.

Expert Member

4.

Hafiz Muhammad Asif,

Assistant Professor Faculty of Health and medical

Sciences Department of Eastern Medicines and Surgery,

University of Poonch (Rawala Kot), AJ&K.

Expert Member

5.

Dr. Lajbar Khan,

Ex-Chief Scientific Officer, Medicinal Botanic Centre,

PCSIR Laboratories Complex, Peshawar.

Expert Member

6.

Dr. Shahzad Hussain,

Chief, DC & TMD, NIH

(Ex- Officio Member)

Ex-Officio Member

7.

Dr. Amjad Ali,

Chief, Nutrition Division, NIH

Ex-Officio Member

8. Mr. Muhammad Amin,

Deputy Director (PER Division)

Observer

-Not Present-

9. Mr. Adnan Faisal Saim,

DDC, QC (1&2)

Observer

Meeting started with recitation of the Holy Quran and Darud on the Prophet (PBUH). Secretary of the

Committee presented Agenda of the Meeting and following decisions were made by the Committee.

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ITEM NO. 1. GRANT OF ENLISTMENT CERTIFICATE TO THE MANUFACTURERS

Enlistment Evaluation Committee (EEC) examined and discussed the record / panel inspection

reports of the following firms on the basis of recommendations of the panel of inspectors for the grant of

enlistment certificates for manufacturing authorization.

S. No. Name and address of the

Manufacturer

Name of approved Sections/

Decision

1. M/s. PDH Health Care, 42 Nicholson

Road, Lahore.

Sections:- 1. Topical Semisolid Section

(Cream/ointment)

2. Dry Powder sachet section

2. M/s. Nutrix Health Care, Plot No 44

Street No 3 small industrial Area 9KM

Summandari Road Faisalabad.

Section:-

1) Tablet

2) Oral Liquid

3) Dry Powder Sachet

3. M/s. Nutrifactor Laboratories (Pvt) Ltd,

Plot No 4-B,Value Addition City,

Khurrianwala, Fasilabad

Section:-

1) Tablet

2) Capsule

4. M/s. Hisun Pharmaceutical Industries (

Natural Division )

Plot No 37-A,R-02,Industrial Estate Gadoon

District, Swabi KPK

Section:-

1) Tablet

2) Liquid Syrup

3) Capsule

4) Ointment / Cream

5) Powder/ Sachet

5. M/s. Adcok Pharmaceuticals (Pvt) Ltd,

Plot No 3-3-km, Defence off Raiwind Road

,Near Lahore Univerisity Lahore.

Section:-

1) Tablet

2) Liquid Syrup

3) Sachet

6. M/s. Arise Pharma,Plot No.626-Sunder

Industrial Estate Lahore

Section:-

1) Tablet

2) Capsule

3) Syrup

4) Dry Powder Sachet

5) Cream/ointment

7. M/s. KM Pharmaceutical Chak # 118/10-

R Tehsil Jahanian Distt Khanewal

Section:-

1) Liquid

2) Tablet

3) Granulation

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8. M/s. Avant Pharmaceuticals (Pvt)Ltd (

Nutraceuticals Division)Plot No.

4/103,4/104,Sector21,Korangi Industrial

Area,Karachi

Section:-

1) Tablet

2) Liquid

9. M/s. Xenon Laboratories (Pvt) Ltd,9.5-

km Sheikhupra Road,Lahore .

Deferred for rectification of observations

identified in the inspection report and

re.verification of manufacturing facilities

as per SOP approved by the EEC for the

relevant sections

10. M/s.Cure Inn Phytoceuticals (Pvt)Ltd

Plot no 10,11 C ,Punjab Small Industrial

Estate,44-Km from Lahore,Ferozepur Road

,Kasur

Deferred for rectification of observations

identified in the inspection report and

re.verification of manufacturing facilities

as per SOP approved by the EEC for the

relevant sections

11. M/s.Sindhco Nutraceutical 6-D,small

industrial Estate,8-km,from Kasur

,Ferozepur Road,Kasur

Approved

Section:-

1. Oral Liquid

2. Tablet

3. Capsule

4. Sachet

5. Cream /ointment

1.

12. M/s. Avanza Healthcare (Pvt) Ltd. Plot

No.45-A Sundar Industrial Estate,Sundar-

Raiwind Road,Lahore

Sections:-

1) Tablet

2) Capsule

3) Sachet

4) Oral Liquid

A. Not Recommended by Panel

1 M/s MTI Medial

(Pvt.)Ltd,

589-587,Sunder

Industrial Estate,Lahore

Sections:-

01-07-2016 1) Dr.Muham

mad

Saleem

Ex.DG

(PCSIR)

,Member

Advisory

Committee

2) Mr.Asim

Rauf. Fedral

Inspector of

Drug,DRAP,

Lahore

Committee rejected

the application due to

the reasons given in

the Inspection Report

by the panel

including the

following

1) . Herbal unit

was located

on the first

floor above

cephalospori

n injection

section in the

same

building

producing

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allopathic

medicine.

2) Raw material

store was to

be borough

form back

side of the

building

through

stairs. De-

dusting area

was open at

the deck of

the stairs and

de-dusting

area was

separated

from

microbiology

testing

laboratory

thorough

glass

partition

3) Packing

material is to

be brought

from main

entrance of

the allopathic

manufacturin

g facility.

4) Tablet

section is

built-

alongside

main

Quality

Control

Laboratory

separated by

glass

partition.

5) Ointment/Cre

am section

was

compartment

alized with

open upper

common

area.

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6) Finished

goods store

was

combined

with

allopathic

storage area.

7) Capsule

section has

no polisher

Only one pharmacist

was hired for the

whole project while

is was planned to

utilize the technical

strength from

allopathic facility.

Decision:-

1) EEC rejected the application for the grant of enlistment due to above mentioned

observations in the inspection report.

2) The applicant may apply afresh after fulfillment of prescribed criteria.

ITEM:-III GRANT OF ENLISTMENT CERTIFICATES TO IMPORTERS AS

AN AGENTS OF PRINCIPLE MANUFACTURERS.

A. Application for Enlistment as agent of abroad Principal Manufacturer meeting

the prescribed criteria

1. M/s. Hivet Animal Health Business(Vet), 667-P, M.A Johar Town Lahore. As

agent of M/s. Zoopan S.A Rua da Liberdade 77,2050-023 Aveiras de Baixo,

Portugal.

2. M/s. A.S.M Pharma, 47-Basement(Vet), Al Miraj Arcade, Chouburji, Lahore.

As agent of M/s. TAV Veterinaria s.l C/Diagonal 6, Sant Marti de Centelles-

Barcelona, Spain.

3. M/s. Natures Edge(Vet), Plot 17, Street E-3, RCCI Industrial Estate, Rawat,

District, Rawalpindi. As agent of M/s. Minh Dung Veterinary-Aquaculture

Medicines Company Ltd, Vietnam.

4. M/s. Ghazi Brother, Ghazi House(Vet), D-35, KDA Scheme No.1, Miran

Muhammad Shah Road, Karachi. As agent of M/s. Shangai Walcom Bio-

Chem Co., Ltd, China.

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5. M/s. Ghazi Brother, Ghazi House,(Vet) D-35, KDA Scheme No.1, Miran

Muhammad Shah Road, Karachi. As agent of M/s. Evans Vanodine PLC,

Brierley Road, Walton Summit Bamber Bridge Preston, Lancashire, UK.

6. M/s. Sigma Pharma International, 46-E/3, Block-6, PECHS, Karachi. As

agent of M/s. NBTY 2100 Smithtown Avenue, Ronkonkoma, New York,

USA.

7. M/s. Filix Pharmaceuticals (Pvt) Ltd, Plot No.4-B Main Road RCCI Rawat,

Rawalpindi. As agent of M/s. Biotron Laboratorie, Inc. 750 North 1250 West

Centerville, UT 84014, USA.

8. M/s. Bristol Mayer Biotech, 69-A Guldasht Town, Zarar Shaheed Road,

Lahore Cantt. As agent of M/s. OFI Officina Farmaceutica Italiana S.p.a. via

verga n. 14-24127 Bergamo, Italy.

9. M/s. Paradigm Pharmaceuticals office # 16 first floor, Sheen Towers, Block-6,

Shahran-e-Faisal Karachi. As agent of M/s. Lab.it.Biochim.Farm.co

Lisapharma S.P.A Via Licinio, 22036 Erba, Como, Italy.

10. M/s. Iqra Corporation Flat No. C-212, 2nd Floor, Marhaba Apartments Plot

LR 9/31/8 Shoe Market Lawrence Road, Karachi agent of M/s. Goerlich

Pharma GmbH, Germany

11. M/s. Iqra Corporation Flat No. C-212, 2nd Floor, Marhaba Apartments Plot LR

9/31/8 Shoe Market Lawrence Road, Karachi agent of Lysi 101 Reykjavik,

Iceland Decision

The Enlistment Evaluation Committee considered the applications/ record and

evaluated the application for enlistment of the above firms and granted approval for

Enlistment Certificates on Form-6. It was also decided that product specific free sale

certificates shall be required for the Importers who want to import from the principal

having multiple agreements with the Pakistani Importers. Only one similar

formulation could be enlisted into Pakistan for a particular product by any of the

agent.

ITEM: - 4 GRANT OF PRODUCT ENLISTMENT CERTIFICATE TO THE

MANUFACTURERS & IMPORTERS AS AGENT OF PRINCIPAL

MANUFACTURERS.

Sub Committee of the Enlistment Evaluation Committee for Products, evaluated the

products of following companies in its 4th

Meeting and Minutes of the subcommittee are

placed at Annexture A.

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Decision:-

Enlistment Evaluation Committee confirmed the minutes of the 4th

meeting of

sub-committee held on 15-16 August 2016 to evaluate the applications and issue letters to

the manufacturers / importers included in the agenda subject to fulfillment of criteria. The

committee unanimously decided to approve up to thirty (30) products per section. It was

also agreed that recommended conditions for use for vitamin preparations, multivitamin

preparations, multivitamin & mineral preparations and mineral preparations shall be in

accordance with the multivitamin-mineral products monograph. The enlistment

committee decided that shelf life shall be two years for all products except vitamin mineral

liquid preparations. However, request for enhancement in shelf life shall be entertained on

the basis of stability data generated in compliance with the WHO stability guideline for the

relevant products.

ITEM: - 5 BRAND NAME FOR THE GRANT OF PRODUCT ENLISTMENT

CERTIFICATE TO THE MANUFACTURERS & IMPORTERS AS

AGENT OF PRINCIPAL MANUFACTURERS.

Brand names of the products resemble with the already registered more than 80,000 registered

products. So it becomes non practicable to issue enlistment certificates avoiding similarity in

brand names. As applicable in most of the countries of the world that such products are

represented by adding the first word of the name of the manufacturer as prefix before the brand

name. This would make it possible to avoid similarity in brand names without affecting the

rights of the already registered/enlisted products. It is therefore proposed that product

enlistment certificates may be issue on form 7 by adding companies/forms name before the

proposed brand name.

Decision:- Enlistment Evaluation committee agreed to the proposal for the issuance of brand

name by adding first word of the company name as prefix to the brand name to

avoid controversies regarding brand name resemblance.

ITEM: - 6 MANUFACTURERING REQUIREMENTS OF VARIOUS

CATOGERIES OF ALTERNATIVE MEDICINES AND HEALTH

PRODUCTS.

Manufacturers of various categories of products falling under the jurisdiction of health

and OTC products division have been continuously insisting that their manufacturing

facilities may be defined as per Indian model. Pakistan Tibbi Pharmaceuticals

manufacturers Association has been continuously requested to adopt the schedule T of

the Indian Drugs and Cosmetic act 1940 for the purpose of Unani Medicine. Likewise

Homeopathic industry required to adopt the Homeopathic model. A number of

consultative meetings were conducted with the PTMA and it was agreed.

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So proposal have been prepared for consideration of the enlistment Evaluation

Committee (EEC) in the form of standard operation procedures for various categories of

facilities as under.

1) Unani Medicine Annex B (Indian Model).

2) Homeopathic Medicine Annex C (Indian Model).

3) Medicated Cosmetics, medicated soaps and medicated Shampoos Annex D (Indian

Model).

4) Nutraceuticals that is Food Supplements, probiotics disinfectants and

Phytomedicines Annex E (Pakistan GMP Model).

Decision:-

Enlistment Evaluation Committee after detailed Evaluation of the proposals

approved standard operating procedure for Enlistment of manufacturers of

following classes as per Annextures mention here in below.

1) Unani Medicine Annex B (Indian Model).

2) Homeopathic Medicine Annex C (Indian Model).

3) Medicated Cosmetics, medicated soaps and medicated Shampoos Annex D

(Indian Model).

4) Nutraceuticals that is Food Supplements, probiotics disinfectants and

Phytomedicines Annex E (Pakistan GMP Model).

ITEM: - 7 EVIDENCE/DATA REQUIREMENTS FOR CLAIMS/INDICATIONS

OF VARIOUS CATOGERIES OF ALTERNATIVE MEDICINES

AND HEALTH PRODUCTS.

A. SOP for submission of evidence for claims/indications

To make an indication or claim based on evidence of traditional use, applicants must first assess the level of the

evidence supporting the claim.

If you hold one of the following four sources of evidence, you hold general level evidence.

1. Approved or recognized Pharmacopoeia or Authoritative Book.

2. Approved Monograph.

3. Three independent written histories of use in the classical or traditional medical literature.

4. Availability through any country’s government public dispensaries for the indication claimed.

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If you hold two of the above sources of evidence, you hold medium level evidence. Of course, the evidence,

whether it is medium or general level, must support the indications or claims that you intend to make for your

product.

If you hold general level evidence, you can make general level indications and claims. These include indications

and claims relating to:

Health maintenance, including nutritional support;

Vitamin or mineral supplementation; and

Relief of symptoms (not related to a named disease, disorder or condition).

If you hold medium level evidence, you can make medium level indications and claims. These include the

following kinds of indications and claims:

Health enhancement;

Reduction of risk of a disease/disorder/condition;

Reduction in frequency of a discrete event;

Aids/assists in the management of a named symptom/disease/disorder/ condition; and

Relief of symptoms of a named disease, disorder or condition.

All indications/claims based on evidence of traditional use must be worded to the effect that "This (tradition)

medicine has been traditionally used for (indication)". This applies to general and medium level

indications/claims.

High level indications and claims are not permitted based on evidence of traditional use.

Similar principles apply to making indications and claims based on evidence of traditional use for homoeopathic

and aromatherapy products.

Detail of guiding SOP for submitting evidence about claims and indications is placed as Annextures F

B. SOP for Data Requirements for Imported Medicines/new Medicines.

Application for enlistment of imported medicines/new medicines which are not authorized locally, requirement

of Data to prove quality, Safety and efficacy of the product is necessary for tolerance, indications/claims, risk

information and other connected aspects of the products. SOP as been prepared as per Indian Model for

evaluation of products applications and to guide the applicants as well as regulators.SOP is placed at Annextures

G.

Decision: - Enlistment Evaluation committee after thorough evaluation of proposal approved the

standard operates procedures for the indications/claims and evidence or data requirement in this regard

including data requirement for the imported and new Medicines. Already enlisted products will also be

reexamined accordingly, while evaluating similar applications. Applications regarding Homeopathic and

Unani combination formulations would be subjected for evaluation and assessment by experts of relevant

specialty, if such combinations are not available internationally.

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ITEM: - 8 PRODUCT ENLISTMENT

1) M/s. Tianshi International Pakistan Co., (Pvt.,) Ltdlocated at theaddressFirst Floor, Bannerstore Shopping Plaza, Block 20-A, Main Civic Centre, G-8 Markaz Islamabad, As agent of Tianjin Tianshi Biological Development Co., Ltd.China

SR.No

Brand name of the product

List of Ingredient with Strength

Common Name of Ingredients

Recommended Use

Pack Size

Decision of EEC

.0001

Tianshi Zinc Capsules Each Capsule contains the following in mg.

1. Anhydrous Glucose…143(PPRC)

2. Egg white powder...50(PPRC) 3. Zinc lactate…4(PPRC) 4. Talc…2(PPRC) 5. Magnesium

stearate…1(PPRC)

1. Anhydrous glucose

2. Egg White 3. Zinc Lactate 4. Magnesium

silicate 5. Magnesium

stearate

Food supplement

Maintenance of good health.

60 Capsules per bottle

Approved subject to

fulfillment of criteria

.0002

Tianshi Spirulina Capsules Each Capsule contains the following in mg.

1. Spirulina…242.50(PPRC) 2. Gelatin…6.25 (PPRC) 3. Magnesium stearate…….1.25

(PPRC)

1. Dried spirulina powder

2. Gelatin 3. Magnesium

stearate

Food supplement


100 Capsulesper bottle

Approved subject to fulfillment of criteria

.0003

Tianshi Lipid metabolic management Tea Each Sachet contains the following in mg.

1. Herbal gynostemma pentaphyllum…390(PPRC)

2. Folium nelumbinis…390(PPRC)

3. Redix polygoni mutiflori…255(PPRC)

4. Greentea...255(PPRC) 5. Semen cassiae…210(PPRC)

1. Ginseng 2. Lotus leaves 3. Fleece flower

root 4. Green tea

5. Cassia seeds.

Food supplement


40 sachet per pack


.0004

Tianshi Grape Extract Capsules Each Capsule contains the following in mg.

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1. Extract of Grape seed…54.25(PPRC)

2. Isomalto-oligosaccharide…259(PPRC)

3. Vitamin C(L-ascorbic acid)……0.35(PPRC)

4. Starch…….35(PPRC) 5. Magnesium

Stearate…1.40(PPRC)

1. Grape Plant Extract

2. Carbohydrates 3. Vitamin C 4. Starch 5. Magnesium

Stearate

Food supplement




.0005

Tianshi Cordyceps Capsules Each Capsule contains the

following in mg.

1. Cordyceps Mycelium Powder…..500(PPRC)

1.Cordyceps

Food supplement


100 Capsules per bottle


.0006

Tianshi Chitosan Capsules Each Capsule contains the following in mg.

1. Chitosan….150(PPRC)

1. Chitosan



.0007

Tianshi Cell Rejuvenation Capsules Each Capsule contains the following in mg.

1. Carrot powder…262.50 (PPRC)

2. Extract of herbal gynostemma pentaphyllum….22.50(PPRC)

3. Tea polyphenol...7.50 (PPRC)

4. VC(as-Ascorbic acid)…6 (PPRC)

5. Separating agent magnesium

stearate1.5(PPRC)

1. Carrot powder, 2. Ginseng 3. Organic

chemical 4. Vitamin C 5. Magnesium

stearate

Food supplement


150Capsules per bottle


.0008

Tianshi Super Calcium Powder with Lecithin

Each Sachet contains the

following in mg.

1. Lecithin

Powder….180(PPRC) 2. Calcium

Carbonate...68(PPRC) 3. Zymolytic Bone calcium

1. Lecithin powder 2. Lime stone 3. Bone calcium 4. Vitamin B 5. Vitamin B12

Food supplement

Maintenance of good

18 Capsules per pack


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powder…40(PPRC) 4. Riboflavin…..0.08(PPRC) 5. Cyanocobalamine....0.000

2(PPRC) 6. L-ascorbic

acid…7.2(PPRC) 7. Taurine….8(PPRC) 8. Folic acid…..0.024(PPRC) 9. Malt

Dextrin….0.695(PPRC) 10. Micro crystal

cellulose……48(PPRC) 11. Starch……22(PPRC) 12. Beta-

cyclodextrin..12(PPRC) 13. Talc…….12(PPRC) 14. Magnesium

Stearate…2(PPRC)

6. Vitamin C 7. Taurine 8. Vitamin B9 9. Polysaccharide 10. Wood pulp 11. Starch 12. Sugar 13. Talc 14. Magnesium

stearate

health.

.0009

Tianshi Super Calcium Powder For Children

Each Sachet contains the following in mg.

1. Whole Milk Powder….5420(PPRC)

2. Zymolytic Bone calcium powder…2200(PPRC)

3. Isomalto oligosaccharide.1500(PPRC)

4. Egg yolk powder…300(PPRC)

5. Vitamin A (Retinol)….0.091(PPRC)

6. VD (colecalciferol)….0.002(PPRC)

7. VC(L-Ascorbic acid)…..6(PPRC)

8. Ferrouslactate…….1(PPRC)

9. Zinc-Lactate…..1.5(PPRC) 10. Taurine…..2.8 (PPRC) 11. Malt Dextrin…33.6 (PPRC) 12. Non-dairy Creamer… 500

(PPRC) 13. Aspartame…35 (PPRC)

1. Dried milk 2. Bone calcium 3. Carbohydrate 4. LecithinPowder 5. Vitamin A 6. Vitamin D 7. Vitamin C 8. Iron 9. Zinc-lactate 10. Taurine 11. Starch 12. Coffee

Whitener 13. Artificial

sweetener

Food supplement


10 sachet in one pack


.00010

Tianshi Super Calcium Powder with Metabolic Factor


1. De-fatted Milk Powder….2680 (PPRC)

2. Zymolytic Bone calciumpowder...2100(PPRC

1. Skimmed milk 2. Bone calcium 3. Sugar 4. Pumpkin

Food supplement

Maintena

10 sachet in one pack


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) 3. Polydextrose...2000(PPRC) 4. Pumpkin

powder….1700(PPRC) 5. Isomalto

oligosaccharide…..1250(PPRC)

6. VA (retinol)…0.106(PPRC) 7. VD

(Colecalciferol)……0.002(PPRC)

8. VB1(Thiamine)….0.15(PPRC)

9. Vitamin B2 (Riboflavin)….0.15(PPRC)

10. VC(L-Ascorbic acid)…..7.5(PPRC)

11. Malt dextrin…27(PPRC) 12. Cocoa powder….200

(PPRC)

13. Aspartame….35(PPRC)

powder 5. Powder 6. Carbohydrate 7. Vitamin D 8. Vitamin B1 9. Vitamin B2 10. Vitamin C 11. Starch 12. Cocoa Powder 13. Artificial

Sweetener

nce of good health..

.00011

Nutrient Super Calcium Powder


1. Isomalto-

oligosaccharide…. 3600

(PPRC)

2. De-fatted Milk Powder….3180 (PPRC)

3. Zymolytic Bone calcium powder…2400(PPRC)

4. VA(retinol)…0.106(PPRC) 5. VD2(colecalciferol)…0.002(

PPRC) 6. VC(L-Ascorbic

acid)…7.50(PPRC) 7. Malt

dextrin….37.392(PPRC) 8. Non-dairy

creamer…500(PPRC) 9. Cocoa

powder…200(PPRC) 10. Aspartame…40(PPRC) 11. Essence...20(PPRC) 12. Vanillin…10(PPRC) 13. Ethyl Maltol…5(PPRC)

1.carbohydrate

2.skimmed milk

3.Bone calcium

4.Vitamin A

5.Vitamin D2

6.Vitamin C

7.Starch

8.Red seaweed

(thickening agent)

9.Theobram powder

10.Sweetener

11.Essence

12.Vaniline

13.Flavourant

Food supplement


10 sachet in one pack.


2) Otsuka Pakistan Limited as agent of Thai Otsuka Pharmaceutical Co,Ltd.

Aminoleban oral supliment

No. Common name ingredients List of ingredients with strength

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(amount (g) /100 g)

1 Maltodextrin 49.459788 2 Sodium caseinate 1.04

3 Rice bran oil 7.37

4 Mixed tocopherols concentrate 0.00474

5 Sucrose esters of fatty acids 0.27

6 Deoiled enzyme-modified soy

lecithin

0.72

7 Peptide PBF 13.00

8 Sucrose 5.085

9 Citric acid anhydrous 3.00

10 Orange flavor (Natural flavor) 4.00

11 Orange color 0.70

Amino acid 12 L-Valine 3.204

13 L-Leucine 4.074

14 L-Isoleucine 3.845

15 L-Threonine 0.266

16 L-Tryptophan 0.147

17 L-Arginine.HCl 0.604

18 L-Histidine.HCl.H2O 0.375

19 L-Lysine.HCl 0.485

20 Carnitine 0.050

Mineral 21 Magnesium sulfate.7H2O 0.41

22 Potassium dihydrogen phosphate 0.34

23 Potassium chloride 0.25

24 Potassium iodide (2% dilute) 0.00125

25 Calcium glycerophosphate 0.61

26 Sodium ferrous citrate 0.025

27 Potassium sorbate 0.15

28 Disodium glycyrrhizinate 0.26

29 Copper sulfate.5H2O 0.00103

30 Zinc sulfate.7H2O 0.04397

31 Manganese sulfate.H2O 0.00124

32 Potassium acetate 0.114

Vitamin 33 Cyanocobalamin (Vitamin B12)

(0.1%)

0.001

34 Phytonadione (Vitamin K1) (50%

powder)

0.000022

35 Riboflavin (Vitamin B2) 0.00031

36 Thiamine.HCl (Vitamin B1) 0.00025

37 Pyridoxine.HCl (Vitamin B6) 0.00049

38 Folic acid (Vitamin M) 0.00010

39 Biotin (1% trituration) (Vitamin

H)

0.005

40 Retinol Palmitate (Vitamin A

175,000 IU/g)

0.00531

41 Cholecalciferol (Vitamin D3

200,000 IU/g)

0.00047

42 Sodium ascorbate (Vitamin C) 0.01380

43 DL-alpha-tocopheryl acetate

(Vitamin E acetate 50% powder)

0.03720

44 Calcium pantothenate (Vitamin

B5)

0.002380

45 Nicotinic acid (Niacin) 0.003050

46 Choline bitartrate 0.02460

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Decision:- Approved subject to fulfillment of criteria.

4.WERRICK PHARMACEUTICALS( HEALTH & OTC DIVISION) to be contract manufactured by M/s Wilson

health care Islamabad

Sr

# Name of Product

Submission

Date

Fee

Deposit

Demanded

Pack Size

Demanded

Price

Decision

of EEC

1

PlantCal Insta Sachets

Each Sachet Contains:

1) Calcium from Red Algae

(Lithothamnium Calcareum)…..1000 mg

2) Vitamin D 3 (USP) (100 IU/1 mg)…..4 mg

3) Vitamin K 2 (Menaquinones) USP…..25 mcg

4) Vitamin C (USP)…..500 mg

5) Vitamin B 6 (USP)…..10 mg

6) Iron…..2 mg

7) Zinc Citrate(USP)…..5 mg

8) Magnesium…..22 mg

Other Trace Elements Iodine, Manganese,

Potassium and Boron

31/12/2015 2000 10’s Rs:450.00

Approved

subject to

fulfillment

of criteria

and

clarification

from the

authority

about fee

to be

charged as

per policy

decision in

35th

meeting of

the

Authority

3 WILSON'S HEALTHCARE

Sr

# Name of Product

Fee

Deposit

Submission

Date

Demanded

Pack Size

Decision of

EEC

1

Meco-12 Softgels

Each Softgel Contains:

Mecobalamin…..500mcg

2000 02/09/2014 10's

Approved subject

to fulfillment of

criteria

2

Orchard Syrup Smokers

Each 5ml Contains:

Pelargonium Sidiodes…..13mg

Menthol…..0.83mg

250 02/09/2014 120ml

Approved subject

to fulfillment of

criteria

3

Serotin EC Capsules 80000IU

Each Capsule Contains:

Serrapeptase…..80000IU

2000 30/09/2014 30's

Approved subject

to fulfillment of

criteria

Minutes of 14th



17 | P a g e

or the

Authority

will define

the fees.

2

PlantCal Tablets

Each Tablet Contains:

1) Calcium from Red Algae

(Lithothamnium Calcareum)…..1000 mg

2) Vitamin D (USP) (100 IU/1 mg)…..4 mg

3) Vitamin K 2 (USP)…..25 mcg

4) Vitamin C (USP)…..50 mg

5) Vitamin B 6 (USP)…..10 mg

6) Iron…..2 mg

7) Zinc Citrate(USP)…..5 mg

8) Magnesium…..32 mg

Other Trace Elements Iodine, Manganese,

Potassium and Boron

31/12/2015 2000 30’s Rs:1350.00

Approved

subject to

fulfillment

of criteria

and

clarification

from the

authority

about fee

to be

charged as

per policy

decision in

35th

meeting of

the

Authority

or the

Authority

will define

the fees.

3

WholeMega Softgels 1000mg *


1) Salmon Fish Oil(USP)…..1000 mg

Total Omega-3 Fatty Acids…..379.9 mg

EPA (Eicosapentaeonic Acid).....190 mg

DHA (Docosahexaenoic Acid)...132.6 mg

Other Omega-3 Fatty Acids.....57.3 mg

Total Omega-6 Fatty Acids.....36.9 mg

Total Omega-5,7 & 8 Fatty Acids.....2.2 mg

Total Omega-9 Fatty Acids.....243.1 mg

* Values may vary from ±5%

17/08/2016 Rs:2000 30’s Rs:1675.00

Approved

subject to

fulfillment

of criteria

and

clarification

from the

authority

about fee

to be

charged as

per policy

decision in

35th

meeting of

the

Authority

Minutes of 14th



18 | P a g e

or the

Authority

will define

the fees.

Minutes of 14th



19 | P a g e

5.SCOTMANN PHARMACEUTICALS ( HEALTH & OTC DIVISION)to be contract manufactured by M/s Wilson

health care Islamabad

Sr

# Name of Product

Submission

Date

Fee

Deposit

Demanded

Pack Size

Demanded

Price

Decision

of EEC

1

AfterBiotic Capsules


Total Probiotic Blend…..30mg

(Composed of the following strains)

Lactobacillus acidophilus……3 billion

Bifidobacterium Lactis…..….3 billion

Inulin (FOS Prebiotic 100mg)

31/12/2015 2000 10's 3000.00

Approved

subject to

fulfillment

of criteria

and

clarification

from the

authority

about fee

to be

charged as

per policy

decision in

35th

meeting of

the

Authority

or the

Authority

will define

the fees.

2

Emkay-D Softgels


MK-7 (Vitamin K2 as Menaquinone-7)(USP)…..100

mcg

(From Natto Extract)

Vitamin D-3 (Cholcalcefirol)(USP)…..2000 IU

31/12/2015 2000 10's 1000.00

-do-

3

Femence Capsules


Total Probiotic Blend…..5x108 Viable Cells

(Composed of following strains)

Lactobacillus reuteri

Lactobacillus rhamnosus

Cranberry Extract…..50mg

31/12/2015 2000 14's 1600.00

-do-

4

SunnyD 5000 Softgels


Vitamin D-3 Cholecalciferol(USP) ….. 5000 IU

31/12/2015 2000 30's 1000.00

-do-

5

SunnyD Drops

Each Drop Contains:


31/12/2015 2000 1's (10ml) 900.00

-do-

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20 | P a g e

6

SunnyD Jr Spray

Each Spray Contains:


31/12/2015 2000 1's (15ml) 900.00

-do-

7

SunnyD STAT Softgels


Vitamin D-3 (Cholecalciferol )(USP) 200000 IU

31/12/2015 2000 1's 500.00

Approved

after

clarification

8

Sunny Dee 10000IU Softgels


1)Vitamin D3 (Cholecalciferol) (USP)…..10000IU

8/12/2016

2000

20's,

30's

& 60's

600.00,

900.00 &

1800.00 -do-

9

Sunny Vit Softgels


Vitamin D-3 (Cholecalciferol )(USP) 200000 IU

30/08/2016 2000 1's 500.00

-do-

7.FOCUS AND RULES

SR.

NO

BRAND NAME & COMPOSITION

LIST OF INGREDIENTS

COMMON NAME OF

INGREDIENTS

RECOMMENDED

USE

PACK

SIZE

Decision

of EEC

1

ACTIPRO TABLET


General Asthenia,

Fatigue, Lethargic

conditions

10’s

Approved

subject to

fulfillment

of criteria.

Centella asiatica(API)……………………….500mg Herba Centellae 20’s

Withania somnifera(USP)…………………...100mg Radix Withaniae (Root

Extract) 30’s

Herpestis monniera (BP)…………………......50mg Bacopa monnieri

(Leave Extract) 100’s

2

ANACID SYRUP

Each 5ml of the Syrup Contains:

For Dyspepsia,

Hyper Acidity and

Associated

Symptoms

60ml

-do-

Berberis aristata (BP)…………………..60mg Indian Barberry or Tree

Turmeric 90ml

Cinnamomum tamala (API)………........50mg Indian cassia (Dried

Stem Part) 120ml

Coriandrum sativum (API)……………..10mg Coriander (Seed

Extract)

Cuminum Cyminum (API)…………......100mg Cumin (Seed Extract)

Foeniculum vulgare (API)……………...100mg Sweet Fennel (Seed

Extract)

Vitis Vinifera (API)…………………….100mg Ripe Dried Grape (Fruit

Extract)

Mesua Ferrea (API)……………………..60mg Cobra's Saffron

Glycyrrhiza glabra (BP)……………….60mg Glycyrrhiza (Root

Extract)

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Mentha piperita (BP)…………………….100mg Brandy Mint (Leave

Extract)

3

GINKOBA SYRUP


IVY

60ml

-do- Ginko biloba

(USP)…………………………..125mg

Ginkgo biloba (Leave

Extract) 90ml

120ml

4

GINKOBA CAPSULE


Cerebral Circulatory

Insufficiency

10’s

-do- Ginko biloba (USP)………………………120mg Ginkgo biloba (Leave

Extract) 20’s

30’s

100’s

5

IVY SYRUP


Expectorant & Anti-

tussive

60ml

-do- Hedera helix L., folium (BP)…………….35mg Ivy Leave (Leave

Extract) 90ml

120ml

6

GRAF CAPSULE


Anti-oxidant

10’s

-do- Vitis vinifera (API)………………….500mg Grape Fruit (Fruit

Extract) 20’s

30’s

100’s

7

FOCUS ROSE WATER Mild astringent 60ml

-do- Rosa centifolia L (USP) (1:1)

Arqe gulab (Flower

Extract) Flavoring agent 90ml

Rose water Perfuming agent 120ml

Rose distillate

8

CORAZON/CARDIN/DENCARD CAPSULE


Cardiology

10’s

-do- Salvia miltiorrhiza (USPHMC)…………….250mg

Danshenform

Compound (Root

Extract)

20’s

30’s

100’s

9

D-PRES/D-CLAR CAPSULE


Anti-Depressant

10’s

-do- Hypericum perforatum (BP)…………..300mg St. JhonWort (Rhizome

Extract) 20’s

30’s

100’s

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10

GARLICON CAPSULE


Carminative

10’s

-do- Allium sativum L. (BP)……………….300mg Garlic (Fruit Bulb

Extract) 20’s

30’s

100’s

11

MENORA PLUS CAPSULE


Male Infertility &

Reproductive

Disorders

10’s

-do-

Payusinystalia Yuhimbe (ABC)………………75mg Yohimbe (Bark Extract) 20’s

Tribulus Terrestris (BP)…………………......250mg Puncture vine (Fruit

Extract) 30’s

Withania Somnifera (USP)…………………200mg Radix Withaniae(Root

Extract) 100’s

Erysimum (Cheiranthus) cheiri

(EMA;HPMC)……………75mg Wall Flower

Asparagus adscendens (ABC)…………….100mg Asparagus (Rhizome

Extract)

Amomum subulatum(BP)…………………25mg

Greater Cardamom

(Dried Ripened Fruit

Extract)

Orchis latifolia (API)………………………100mg Salep (Root Extract)

Sidacordifolia (API)……………………….75mg Kharethi(Root Extract)

Crocus sativus (API)……………………….15mg Saffron (Dry Styles &

Stigma Thread Extract)

Asphiatum puniabinum (API)……………...20mg Shilajit (Tar)

12

GYNEX CAPSULE


Treatment for

gynecological

disorders, which has

been clinically

proven in different

conditions like

abnormal vaginal

discharge,

dysfunctional

uterine bleeding,

dysmenorrhea,

premenstrual

syndrome and

menorrhagia.

10’s

-do-

Saraca indica (API)…………………….1000mg AáOKA (Legume

Extract) 20’s

Symplocos recemosa (API)…………….150mg Lodhra (Dried Stem

Bark Extract) 30’s

Valeriana wallichii (API)……………….150mg TAGARA (Dried

Rhizome Extract) 100’s

Matricaria chamomilla (BP)…………….150mg

Wild

Chamomile.(Flower

Bud)

13

BONVIT TABLETS


Dietary Supplement

for Bones

10’s

-do- Glucosmin Shulphate (USP)…………….750mg GS, Chitosamine 20’s

Chondroitin Shulphate (USP)……………600mg Chondroitin Shulphate 30’s

100’s

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23 | P a g e

14

BIOSKIN CAPSULE


Vitamin B7/Vitamin H For Biotin

Deficiency

10’s

-do- Biotin (USP)……………………5000mcg 20’s

30’s

100’s

15

CALCID TABLET

Minerals &

Vitamins

Supplement

10’s

-do-

EACH TABLET CONTAINS:

Calcium Carbonate (USP)……………1000mg Lime stone 20’s

Cholecalciferol (Vitamin D3) (USP)………..800IU Vitamin D3 30’s

Vitamin A (Retinol)

(USP)…………………..1000IU Vitamin A 100’s

Phytonadione(Vitamin K2 MK7)

(USP)………….80mcg Vitamin K2 MK7

Magnesium(USP)…………………………….100mg Magnesium

Zinc(USP)…………………………………….15mg Zinc

16

ELERON TABLET

Iron Iron Supplement

10’s Rejected

because

iron

content is

above the

limit

Each tablet contains:

Iron (as ferrous sulfate / fumarate)

(USP)…………………….100mg

20’s

30’s

100’s

17

UCRAN SACHET

Each Sachet Contains: For the treatment of

Urinary Tract

Infection

10’s Approved

subject to

fulfillment

of criteria Vaccinium microcarpum (USP)……………..250mg

Cranberry Extract (Fruit

Extract) 30’s

18

LIVIGAR CAPSULE


Liver Tonic

10’s

Approved

subject to

fulfillment

of criteria

Eclipta Elba (API) (1:1)…………….250mg False daisy (Root

Extract) 20’s

Picrorhiza kurroa (API) (1:1)…………100.0mg Kutki (Rhizome

Extract) 30’s

Solanum nigrum (API) (1:1)

…………….150.0mg

Hound's berry

(Berry/Fruit Extract) 100’s

Cichorium Intybus (EMA;HPMC)

(1:1)…………175.0mg

Chicory root (Root

Extract)

Boerhaavia diffusa (API) (1:1)……….100.0mg Punarnava (Fruit

Extract)

Tamarix gallica (EMA;HPMC)

(1:1)…………100.0mg French tamarisk

(Root/Flower Extract)

Sphaeranthus Indicus (USP;HMC)

(1:1)…….50.0mg

East Globe Indian

Thistle (Fruit Bud

Extract)

Raphanus sativus (API) (1:1)……...50.0mg Mulaka (Root Extract)

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24 | P a g e

Berberis Aristata (API) (1:1)………….150.00mg Dronapushpi (Whole

Plant Extract)

Silybum Marianum (BP)

(1:1)………….200.00mg Milk thistle Fruit (Fruit

Extract)

Glycyrrhiza Glabra (BP) (1:1)……….200.00mg Liquorice root (Root

Extract)

19

LIVIGAR SYRUP


Liver Tonic

60ml

Approved

subject to

fulfillment

of criteria

Eclipta Elba (API)………………………..50mg False daisy (Root

Extract) 90ml

Picrorhiza kurroa (API)…………………..10mg Kutki (Rhizome

Extract) 120ml

Solanum nigrum (API)…………………….50mg Hound's berry

(Berry/Fruit Extract)

Cichorium Intybus (EMA;HPMC)……….50mg Chicory root (Root

Extract)

Boerhaavia diffusa (API)…………………20mg Punarnava (Fruit

Extract)

Tamarix gallica

(EMA;HPMC)……………………..10mg

French tamarisk

(Root/Flower Extract)

Sphaeranthus Indicus (USP;HMC)………..10mg

East Globe Indian

Thistle (Fruit Bud

Extract)

Raphanus sativus (API)…………………...25mg Mulaka (Root Extract)

Berberis Aristata (API)……………………..20mg Dronapushpi (Whole

Plant Extract)

Silybum Marianum (EMA;HPMC)………...20mg Milk thistle Fruit (Fruit

Extract)

Glycyrrhiza Glabra (EMA;HPMC)…………50mg Liquorice root (Root

Extract)

20

VITARELCAPSULE


Fatigue

Neurasthenia

Mental Exhaustion

Nutritional

deficiencies

Geriatric disorders

10’s

Approved

subject to

fulfillment

of criteria

Eleutherococcus Senticosus

(EMA;HPMC)……….200mg

Eleutherococcus

(Ginseng) root (Root

Extract)

20’s

Medicago Sativa (BP)……………….400mg Alfalfa (Whole Plant

Extract) 30’s

Emblica Officinalis (API)……………800mg Amalaki (Fruit Extract) 100’s

Trigonella Foenum Gracum

(EMA;HPMC)……………..500mg

Fenugreek (Seed

Extract)

21

VITARELSYRUP


Fatigue

Neurasthenia

Mental Exhaustion

Nutritional

deficiencies

Geriatric disorders

60ml

Approved

subject to

fulfillment

of criteria


(EMA;HPMC)……….100mg

Eleutherococcus


Extract)

90ml

Medicago Sativa (BP)………………….250mg Alfalfa (Whole Plant

Extract) 120ml

Emblica Officinalis (API)………………400mg Amalaki (Fruit Extract)

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25 | P a g e

Trigonella Foenum Gracum

(EMA;HPMC)…………………………..250mg

Fenugreek (Seed

Extract)

22

TOSRIL SYRUP


Antiseptic, cough

reliever, and

expectorant

preparation.

60ml

Approved

subject to

fulfillment

of criteria

Adhatoda vasica (API)…………………300mg Vasa (Leave Extract) 90ml

Viola odorata (API)…………………….12.5mg Banaksa (Flower

Extract) 120ml

Piper longum (API)……………………..50mg Chavya (Stem Extract)

Cordia latifolia (BP)…………………….50mg Cordia (Flower Extract)

Hyssopus officinalis (BP)……………….50mg Hyssop (Whole Plant

Extract)

Alpinia galangal (API)………………….50mg blue ginger (Rhizome

Extract)

23

COFIX PLUS SYRUP


Expectorant & Anti-

tussive

60ml

Approved

subject to

fulfillment

of criteria

Hedera helix L., folium (BP)…………………35mg Ivy Leave (Leave

Extract) 90ml

Glycyrrhiza glabra (BP)…………………75mg Glycyrrhiza glabra

(Root Extract) 120ml

24

URGE CAPSULE


Male Infertility &

Reproductive

Disorders

10’s

Approved

subject to

fulfillment

of criteria

Payusinystalia Yuhimbe (ABC)……………75mg Yohimbe (Bark Extract) 20’s

Tribulus Terrestris (BP)…………………….300mg Puncture vine (Fruit

Extract) 30’s

Withania Somnifera (USP)…………………200mg Radix Withaniae(Root

Extract) 100’s

Erysimum (Cheiranthus) cheiri

(EMA;HPMC)………………………………75mg Wall Flower

Asparagus adscendens (ABC)……………….100mg Asparagus (Rhizome

Extract)

Amomum subulatum(BP)……………………25mg

Greater Cardamom

(Dried Ripened Fruit

Extract)

Orchis latifolia

(API)…………………………100mg Salep (Root Extract)

Sidacordifolia (API)…………………………..15mg Kharethi(Root Extract)

Crocus sativus (API)…………………………..15mg Saffron (Dry Styles &

Stigma Thread Extract)

Asphiatum puniabinum

(API)……………………20mg Shilajit (Tar)

25

VIGIRAL TABLET


General Asthenia,

Fatigue, Lethargic

conditions

10’s Approved

subject to

fulfillment

of criteria

Tribulus Terrestris (BP)…………………250mg Puncture vine (Fruit

Extract) 20’s

Withania somnifera(USP)……………….200mg Radix Withaniae (Root

Extract) 30’s

Minutes of 14th



26 | P a g e

Payusinystalia Yuhimbe (ABC)…………75mg Yohimbe (Bark Extract)


(EMA;HPMC)………..20mg

Eleutherococcus


Extract)

Ginko biloba (USP)………………………120mg Ginkgo Biloba (Leave

Extract) 100’s

26

CALCID 600 TABLET


Calcium Carbonate (USP)…………….600mg

Magnesium (USP)……………15mg

Vitamin D3………………..400IU

Zinc………………………...5mg

Calcium

CarbonateMagnesium

Vitamin D3

Zinc

Mineral Supplement

10’s

20’s

30’s

100’s

27

Q-FOL TABLET Each Tablet Contains:

Quatrefolic, [(6S-5-methyltetrahydrofolic acid,

glucosamine salt]……………400mcg

(Vegetarian Source)

Quatrefolic

Methyl tetrahydro folic acid

Folic Acid

Supplement

10’s

20’s

30’s

100’s

Approved

subject to

fulfillment

of criteria

Minutes of 14th



27 | P a g e

3 Site Master File

Site master file template is given below for the Unani Manufacturers to submit information of

the manufacturing facility for enlistment as manufacturers.

Contents

Sr. # Title Page No

1. Brief Introduction of the Manufacturer

2. Name & Address and Contact Persons.

3. Qualified technical staff

4. Description of the Site

5.

Manufacturing and quality control facilities including list of

Sections and other areas of the facility.

6.

Organizational Chart along with job responsibilities of technical

persons for various functions.

7.

Miscellaneous information regarding import export, certifications

and other relevant particulars.

Sr. No Activity Name and Designation Department Signature & date

1 Prepared by

Minutes of 14th



28 | P a g e

2 Reviewed by

3 Approved by Manager/Director/CE

1. BRIEF INTRODUCTION OF THE ORGANIZATION:

-------------------------------------------------------------------------------------------------------------------------------

-------------------------------------------------------------------------------------------------------------------------------

-------------------------------------------------------------------------------------------------------------------------------

-------------------------------------------------------------------------------------------------------------------------------

-------------------------------------------------------------------------------------------------------------------------------

-------------------------------------------------------------------------------

2.Name & Address and Contact Persons.

Site Address

Office Address

3.Qualified technical staff.

Name of Person Office Phone No. Mobile No.

Minutes of 14th



29 | P a g e

4.DESCRIPTION OF THE SITE

5. Manufacturing and quality control facilities including list of Sections and other areas of the facility.

Sr. No

Name of facility and sections.

Area

Sq. Ft

Total Land Area

Total Build up Area

Minutes of 14th



30 | P a g e

6. Organizational Chart along with job responsibilities of technical persons for various

functions

_________________________________________________________________________

_________________________________________________________________________

_____________________________________________________________

8. Miscellaneous information regarding import export, certifications and other relevant

particulars.

Decision: - The committee approved the template of site master file for Unani and

Homeopathic manufacturers only.

minutes of 14th meeting of enlistment evaluation committee ... of 14th me… · nutraceuticals...

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